Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Suspended

CT.gov ID

NCT04060849

Collaborator

Global Life Technologies Corp. (Other)

Enrollment

Locations

Arms

34.9

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase I trial studies the side effects of Nozin in preventing respiratory viral infections in patients undergoing stem cell transplant. Nozin is a non-antibiotic, alcohol-based nasal sanitizer used in hospitals to prevent spread of bacterial infections and may also prevent community acquired respiratory virus infection in stem cell transplant recipients.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Solid Neoplasm	Drug: Nozin Other: Best Practice	Phase 1

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose two times daily (BID) up to 100 days after transplant.

ARM II: Patients receive standard of care.

After completion of study, patients are followed up every week for 6 weeks and then every alternate week until day 100.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)

Actual Study Start Date :

Sep 3, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (Nozin) Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose BID up to 100 days after transplant.	Drug: Nozin Given via nasal single-use popswabs or single-use cotton tipped applicators Other Names: Ethanol-based Intranasal Solution Ethanol-based Nasal Sanitizer Ethanol-containing Nasal Solution
Active Comparator: Arm II (standard of care) Patients receive standard of care.	Other: Best Practice Receive standard of care Other Names: standard of care standard therapy

Arm

Intervention/Treatment

Experimental: Arm I (Nozin)

Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose BID up to 100 days after transplant.

Drug: Nozin

Given via nasal single-use popswabs or single-use cotton tipped applicators

Other Names:

Ethanol-based Intranasal Solution

Ethanol-based Nasal Sanitizer

Ethanol-containing Nasal Solution

Active Comparator: Arm II (standard of care)

Patients receive standard of care.

Other: Best Practice

Receive standard of care

Other Names:

standard of care

standard therapy

Outcome Measures

Primary Outcome Measures

Tolerability of Nozin [Up to 100 days post-transplant]
Will measure and describe reasons for dropout, defined as failure to complete the study to day 100 for any reason. Among participants in the study product arm, reasons for dropout will be classified as either directly related to the product or due to other reasons. Will estimate the proportion of participants who exit the study for reasons directly related to the study product with a precision of +/- 20% (95% confidence interval) to inform tolerability of study product for future studies. Will compare dropout for any reason between treatment arms using Fisher's exact test.
Incidence of adverse events (AEs) [Up to 100 days post-transplant]
AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events will be continually monitored by the study team and descriptively compared between study arms.

Secondary Outcome Measures

Incidence of community acquired respiratory viruses (CARV) [Up to 100 days post-transplant]
Will compare the cumulative incidence of CARV between study arms, counting death as a competing risk. Cox regression will be used to test for differences in the cause-specific hazard of CARV between study arms.
Frequency of respiratory viral symptoms [Up to 100 days post-transplant]
Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms
Number of respiratory viral panel tests [Up to 100 days post-transplant]
Will compare the number of respiratory viral panel tests sent to the lab between study arms using Poisson regression with an offset for the number of days each participant was in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergoing allogeneic hematopoietic transplant for malignant or non-malignant disease
English speaking
Capable of providing informed consent
Planned to receive follow-up at the transplant site for the first 100 days post transplantation
Subjects who the investigator believes can and will comply with the study protocol

Exclusion Criteria:

Documented respiratory viral infection in the two weeks prior to enrollment
Current or planned use of any prophylactic antiviral therapy, antibody treatments, or other agents targeting the prevention of respiratory viruses (i.e. oseltamivir, ribavirin, amantadine)
Known allergy to study drug components (jojoba, orange oil, coconut oil, lauric acid, benzalkonium chloride, vitamin E)
Receiving oxygen supplementation at time of enrollment
Active mucositis at time of enrollment
Ongoing irritation or active infection of the squamous epithelial cell skin involving the nose or nasal vestibule
Daily use of nasal decontamination products or other nasal medications (e.g. nasal steroids)
Unable to complete study procedures (e.g. nasal swab self-testing)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Medicine-Orland Park	Orland Park	Illinois	United States	60462
2	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

Fred Hutchinson Cancer Center
Global Life Technologies Corp.

Investigators

Principal Investigator: Steven Pergam, Fred Hutch/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fred Hutchinson Cancer Center

ClinicalTrials.gov Identifier:

NCT04060849

Other Study ID Numbers:

RG1004525
NCI-2019-05159
10087

First Posted:

Aug 19, 2019

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Ethanol

Pharmaceutical Solutions

Study Results

No Results Posted as of Mar 22, 2022